Pharmaceutical composition for treating bacterial and viral infections

ABSTRACT

The present invention relates to a pharmaceutical; composition comprising an effective amount of vitamin C, zinc, vitamin A, vitamin D3, vitamin B6, garlic and Echinacea to treat bacterial and/or viral infections, and a method for treating bacterial and/or viral infections by orally administering the composition to a patient effective to reduce symptoms of bacterial and/or viral infections such a cold and influenza.

FIELD OF INVENTION

The present invention relates generally to a pharmaceutical compositionand its use. More specifically, the present invention is apharmaceutical composition comprising an effective amount of vitamin C,zinc, vitamin A, vitamin D3, vitamin B6, garlic and Echinacea, to treatbacterial or viral infection, and a method for treating bacterial orviral infection by orally administrating the composition to a patienteffective to reduce the symptoms of bacterial and/or viral infectionssuch as cold or influenza.

BACKGROUND OF INVENTION

To treat bacterial infections a variety of antibiotics drugs areavailable. However, the over-prescription of antibiotics over the pasthalf century give rise to antibiotic resistant strains of bacteria suchas superbugs (1). More than 400 kinds of superbugs are known to causehuman diseases. These diseases include, for example the common cold,influenza, cold sores (Herpes type 1), genital herpes (Type 2),norovirus, mononucleosis, shingles, hepatitis, dengue, West Nile fever,severe acute respiratory syndrome (SARS), Hantavirus, Ebola, andacquired immunodeficiency syndrome (AIDS), especially in cases of thecommon cold and influenza, rapid mutations make it difficult for thebody immune system to identify and react to the invading viruses quickly(1). For viral infections in general, and upper respiratory viralinfections in particular, effective drugs to hinder reproduction of theinfectious agents are much less available. Prescription of anti-fludrugs currently available may reduce complications such as pneumonia,and often viruses are resistant to drugs. As an alternative toconventional pharmaceuticals for treating bacterial or viral infection,interest has grown in the use of certain food supplements for theenhancing or stimulating the immune system in the human body (2). Oneobject of the present invention is to use and alternative composition toenhance or stimulate the immune system of the human body, thus to aidthe body's ability to self-repair.

Wellness can be achieved with the behavioral and lifestyle modificationsutilizing multimodal approaches. For example, with proper diet,especially vegetables, exercise, and botanical alternatives, thisapproach strives to improve the physical and emotional wellness ofpatients. The present inventor has identified certain alternatives. Theinclusion of prevention and wellness management by physicians as astandard of patient care will decrease in medical errors and willcontribute significantly in lowering the cost of health care.

It is therefore an aim of the present invention to provide andalternative composition for treating bacterial or viral infection in apatient, the alternative composition comprising an effective amount ofvitamin C, zinc, vitamin A, vitamin D3, vitamin B6, garlic, andEchinacea; and a method for treating bacterial or viral infection in apatient effective to reduce the symptoms of bacterial and/or viralinfections such as colds and influenza.

DETAIL DESCRIPTION OF THE INVENTION

The present invention is a oral composition comprising an effectiveamount of vitamin C, zinc, vitamin A, vitamin D3, vitamin B6, garlic,and Echinacea that is able to treat bacterial or viral infection in apatient. The oral composition is utilized by either adults or children.The oral composition incorporates active ingredients which functioncooperatively to enhance or stimulate the immune system of the humanbody in order to treat bacterial or viral infection.

Vitamin C (ascorbic acid), is a water-soluble vitamin found in fruit andvegetables, such as citrus fruit (3). It is necessary for the ironabsorption, wound healing and collagen formation. Vitamin C is alsorecognized as being important for the successful productions ofneurotransmitters and improvement of glucose metabolism, its deficiencyresults in neurological disease of scurvy. Vitamin C, which isassociated with immune strengthening, is derived from its ability toenhance the function of the immune system, including antimicrobial andNK cell activities, macrophages, lymphocyte proliferation, chemotaxis,and delayed-type hypersensitivity (3). The recommended daily intake bythe US food and Nutrition Board of the Institute of Medicine for menmore than 18 years old is 90 mg of vitamin C daily; for women more than18 years old, it is 75 mg daily (4). For treating the common cold, 200mg to 3 g have been taken by mouth daily for three to five days orlonger (4).

Zinc salts have been found to inhibit rhinovirus replication in vitro atconcentrations of <0.1 mmole/L, possibly by interfering with rhinovirusprotein cleavage (3). It also has been suggested that zinc salts mayprotect plasma membranes against lysis by cytotoxic agents such asmicrobial toxins and complement. The proposed protective mechanism iseither via immunomodulation or via the binding of zinc ions torhinovirus surface canyons, thus inhibiting viral interactions withintercellular adhesions molecule-1 (ICAM-1), the site of rhinovirusbinding to cells. Because ICAM-1 is also the binding site for leukocytefunction associated antigen-1 (LEA-1), the block of LFA-1/ICAM-1 bindinghas been postulated to possibly suppress inflammation. Severalrandomized, controlled clinical studies showed a beneficial effect ofusing zinc for treating the common cold, particularly when zinc isstarted within the first 24 hours of onset of symptoms (3). The currentrecommended dietary allowance for zinc taken by mouth is: 11 mg formales 19 years and older; and 8 mg for females 19 years and older (5).For the common cold, doses have ranged from 4.5-24 mg of inc (gluconateor acetate) in the form of lozenges taken by mouth every 1-3 hours for3-14 days or until symptoms resolved.

Vitamin A, use as a dietary supplement, for adults and teenagers: oraldosage form (capsules or chewable tablets) has 6-15 mg of beta-carotene(the equivalent of 10.000-25000 units of vitamin A activity) per day(6). For children, the oral dosage is 3 to 6 mg of beta carotene (theequivalent of 5,000-10,000 units of vitamin A activity) per day.

Vitamin D is usually in strengths from 50 to 100 international units(IU), it can be found as a soft gel, capsules, tablets and liquids (7).The 2010 recommended daily allowance (RDA) is 600 IU for those 1-71years of age and 800 IU for those over 71 years of age. For immunefunction, the following doses have been taken by mouth: 40 IU of vitaminD3 daily for 20 years to 100,000 IU of vitamin D3 bimonthly for 12months, or 10,000 IU daily. For the treatment of respiratory infections,2000 IU per kilogram body weight has been taken by mouth daily for threedays. For viral infections, 800 IU of vitamin D has been taken by mouthdaily for two years, followed by 2000 IU of vitamin D daily for 12months. For viral infection, 60,000 IU has been taken by mouth weeklyfor six weeks.

Vitamin B6 refers to a group of chemically similar compounds which canbe interconverted in biological systems. Vitamin B6 is part of thevitamin B group of essential nutrients. Its active form, pyridoxal5-phosphate serves as a coenzyme in some 100 enzyme reactions in aminoacid, glucose and lipid metabolism (10). Vitamin B6 is widelydistributed in foods in both its free and bound forms. Cooking, storage,and processing losses of vitamin B6 vary and in some foods may be morethe 50% depending on the form of vitamin present in the food. Thecurrent Estimated Average Requirements (EARs) for vitamin B6 for womenand men ages 14 and up increase with age from 1.0 to 1.3 mg/day and from1.1 to 1.4 mg/day, respectively; the Recommended Dietary Allowance (RDA)increase with age from 1.2 to 1.5 and from 1.3 to 1.7 mg/day,respectively. It has been reported the B vitamins bolster immuneresponse to fight infection and chronic disease (11).

Garlic (Allium sativum) is one of the oldest medicinal plants used bydifferent cultures (3). The oldest reports of health promotingproperties of garlic dated back to 16^(th) century BC, when over 20ailments were purported from Egypt to be efficiently cured by garlic.Garlic stimulates the immune system and acts as a natural antibiotic,not harmful to the friendly bacteria flora. Many laboratory studies haveconfirmed the antibacterial, antifungal, antivirus, immune-stimulating,and antioxidant properties of garlic. In 1990, the US National CancerInstitute concluded garlic may be a food with cancer-preventiveproperties.

Echinacea, a member of the Compositae family, is a herb widely used totreat and prevent common illness, as it has been shown to haveimmune-stimulating properties (3). Three of nine species in this familyare of medicinal interest (Echinacea angustifolia, E. pallida and E.purpurea). They are commonly used to treat viral upper respiratory tractinfections. Echinacea causes and increase in numbers of circulatingwhite blood cells, activation of phagocytosis by human granulocytes, andelevation of body temperature, resulting from primarily from the aerialportion of E. purpurea and the root portion of E. pallida. Previousresearch suggest the Echinacea may be most effective at reducing theseverity and duration of the common cold when taken early in theillness, but has little to no preventive benefit. A review of fiverandomized, clinical trials investigating the immunomodulatory activityof Echinacea concluded that Echinacea may be an efficacious immunestimulator. For adults (18 years and older), to stimulate the immunesystem, five 400 mg doses of Echinacea have been taken by mouth fourtimes daily for 28 days (8). A dose of 8,000 mg of Echinacea has beentaken by mouth once daily for 28 days. To treat the common cold inadults, 500-1000 mg of Echinacea three times daily for 5-7 days.

In a review of the evidence supporting complementary and alternativemedicine for the treatment and prevention of the common cold inadults(9), it indicated that for prevention, vitamin C demonstratedbenefit in patients subjected to cold stress. There is inconsistentevidence for the Asian ginseng (Panax ginseng) and North Americanginseng (Panax quinquefolius). Allicin (an organosulfur compoundsobtained from garlic) was highly effective in one small trial. Fortreatment, Echinacea purpurea is most consistently useful variety; itwas effective in 5 of 6 trials, likely owing to dose and formulationissues. Overall, the evidence suggests no benefit from probiotics forthe prevention or treatment of the common cold.

In another review of the evidence for interventions aimed at preventingand treating the common cold is frequently of poor quality and resultsare inconsistent (10), it indicated that the best evidence for theprevention of the common cold supports physical interventions (e.g.,handwashing) and possibly the use of zinc supplements. The best evidencefor non-traditional treatments of the common cold supports the use oforal zinc supplements in adults and honey at bed time for cough inchildren over one year.

A study from Egypt showed that 62 patients with the common cold werehelped by giving them either a natural multiherbal formula containing120 mg of Echinacea extract, 100 mg of garlic powder, 200 mg of NigellaSativa oil, and 50 mg of Panax ginseng extract plus vitamin C 50 mg, andelement zinc 7.5 mg (Immumax), or placebo treatment for the duration oftheir symptoms or a maximum of 14 days (3). The researchers found thatwhile the placebo group's average cold duration was eight (5-9) days,the cold duration of the Immumax group was averaging four (3-6) days.Thus, the study showed the use of combination of multiherbal formulaplus vitamin C and zinc is helpful in reducing the duration and severityof common cold symptoms.

It has been reported that a composition and a method for stimulating orenhancing the immune system in a human being (2). The compositioncomprises a mixture of Manapol (a trademark of Carrington Laboratories,Inc., containing acetylated mannans primarily in the form of mannose),beta-1,3-D-glucan, arabinogalactan, elderberry extract, (standardized toabout 30% anthocyanins), zinc gluconate and allicin. The compositiontaken as a food supplement is particularly useful against infectiousdiseases and acts as an anti-bacterial, anti-viral or anti-fungal agent.

The reports cited above have showed that the ingredients of vitamin C,zinc, vitamin D3, vitamin B6, garlic, and Echinacea, each ingredientalone or in combination with some other materials have been used tostimulate or enhance the immune systems of the human body and to treatthe common cold. However, there is no report indicating the use of analternative composition comprising an effective amount of vitamin C,zinc, vitamin A, vitamin D3, vitamin B6, garlic and Echinacea in thetreatment of bacterial or viral infection.

The present invention provides a pharmaceutical composition comprisingan effective amount of vitamin, zinc, vitamin D3, vitamin A, vitamin B6,garlic and Echinacea that is able to treat bacterial or viral infectionin a patient. In on embodiment, the pharmaceutical composition is a oralcomposition. In another embodiment the amount of vitamin C is 1100 mg,the amount of zinc is 55 mg, the amount of vitamin A is 50,000 IU, theamount of vitamin D3 is 200 IU, the amount of vitamin B6 is 30 mg,garlic is 35 IU, and Echinacea is 200 mg in the composition, and thecomposition in tablet form.

The present invention also provides a method for treating bacterial orviral infection in a patient by orally administering a composition tothe patient, wherein the composition comprising an amount of vitamin C,zinc, vitamin A, vitamin D3, vitamin B6, garlic and Echinacea effectiveto reduce the symptoms of bacterial and/or viral infections. In oneembodiment, the viral infection is common cold and influenza. In anotherembodiment, the amount of vitamin C is 1100 mg, D3 is 200 IU, zinc 55mg., garlic 35 IU, vitamin A 50.000 IU, B6 30 mg, Echinacea 200 mg inthe composition, and the composition is in the tablet form. In anotherembodiment, the method further comprises an intervention such as addinga proper diet containing vegetables, and exercising.

As used herein, “a” or “an” means one or more (or at least one)

As used herein, “patient” means either a human being, either adult orchildren using the oral composition.

What is claimed is:
 1. A pharmaceutical composition comprising an amountof vitamin C, zinc, vitamin A, vitamin D3, vitamin B6, garlic andEchinacea effective to treat bacterial and/or viral infections.
 2. Thepharmaceutical composition according to claim 1, wherein the compositionis an oral composition.
 3. The pharmaceutical composition according toclaim 1 wherein the amount of vitamin C is 1100 mg, zinc is 55 mg,vitamin A 50,000 IU, vitamin D3 200 IU, vitamin B6 is 30 mg, garlic is35 IU, and Echinacea is 200 mg, and wherein the composition is in tabletform.
 4. The pharmaceutical composition according to claim 1, whereinthe viral infections is colds or influenza.
 5. A method for treatingbacterial and/or viral infections by orally administering apharmaceutical composition comprising an amount of vitamin C, zinc,vitamin A, vitamin D3, vitamin B6, garlic, and Echinacea to a patienteffective to treat bacterial and/or viral infections.
 6. The method fortreating bacterial and/or viral infections according to claim 5, whereinthe amount of vitamin C 1100 mg, zinc 55 mg, vitamin A 50,000 IU,vitamin D3 200 IU, vitamin B6 30 mg, garlic is 35 IU, and Echinacea is200 mg, and wherein the composition is in tablet form.
 7. The method fortreating bacterial and/or viral infections according to claim 5, whereinthe viral infections is colds or influenza.
 8. The method for treatingbacterial and/or viral infections according to claim 5, wherein themethod further combines with a intervention of using a proper dietcontaining vegetables and exercising.